Vaccine Wars
Local Researchers Take on One of Modern Science’s Most Controversial
Topics

By Tom Sandborn

Two Vancouver scientists, Lucija
Tomljenovic and Christopher Shaw, have recently published a paper that
puts them squarely in the middle of a bitter public debate about
vaccine safety. The UBC researchers argue in their paper that some
components found in many vaccines may be responsible for spiking levels
of autism in the western world. They also acknowledge the
limitations of their study and call for wider ranging epidemiological
and case controlled studies to confirm or deny their
findings.

Everybody seems to have an opinion about vaccines these days, and
passions run high in both lay and scientific circles. Some parents are
debating whether or not to vaccinate their children, having read on the
internet or heard from other anxious parents that vaccination can lead
to autism or other dire diseases in the young. Some doctors are
cautious advocates of vaccine skepticism, while others, who see
vaccination as one of the great, transformative advances in the history
of public health, say that anyone who discourages vaccination has the
blood of children on their hands.

Conspiracy theories abound, on all sides of the debate, with vaccine
skeptics tempted to see vaccine promotion as driven by corporate
profiteering and scientific opportunism and vaccine advocates sure that
anyone expressing caution or skepticism about vaccine safety are part
of a lunatic or larcenous fringe more interested in wealth,
notoriety and sensationalism than in saving children’s lives.

Tomljenovic and Shaw have entered this often acrimonious debate with a
paper published in the November, 2011 issue of the peer reviewed
Journal of Inorganic Biochemistry. (Tomljenovic is a researcher with
the Shaw lab’s Neural Dynamics Research Group, Department of
Ophthalmology and Visual Sciences, at UBC, and Shaw is on faculty at
UBC with the Departments of Ophthalmology and Visual Sciences and
Experimental Medicine and the Graduate Program in Neuroscience. Their
article, “Do aluminum vaccine adjuvants contribute to the rising
prevalence of autism?”(1) takes a look at the remarkable increase
in childhood exposure to injected aluminum salts that has resulted
across the developed world as more and more vaccinations are added to
the list of treatments parents are urged to arrange for their children.
(The aluminum comes into the picture because many vaccines use aluminum
compounds as adjuvants, the substances that increase the impact and
effectiveness of the vaccination. In an earlier paper published in
Neuromolecular Medicine in 2007, Shaw and other researchers reported on
neurological deficits observed in lab animals injected with the
adjuvants used in anthrax vaccines during the Gulf War, including
aluminum hydroxide. (2.)

Tomljenovic and Shaw say that the data they present in their paper
suggest a strong possibility that today’s higher level of childhood
injected aluminum salt exposure through vaccines may be a factor in
increasing the prevalence of autism among children.

(It should be noted that the increase in autism and autism spectrum
disorder diagnoses is itself a subject of scientific disagreement, (3.)
with some authorities holding that the increase in diagnosis is a
result of broader definitions of the disease -expanding “autism” to
include Asbergers and other conditions on an autism spectrum- and of
greater public awareness of autism, leading to increased diagnoses that
may or may not reflect actual increases in the number of children who
are afflicted. For example, Taylor, writing in 2006, commented:

“The recorded prevalence of autism has increased considerably in recent
years. This reflects greater recognition, with changes in diagnostic
practice associated with more trained diagnosticians; broadening of
diagnostic criteria to include a spectrum of disorder; a greater
willingness by parents and educationalists to accept the label (in part
because of entitlement to services); and better recording systems,
among other factors.”
(4.)

Shaw told the Columbia Journal that expansion of diagnostic practice is
not an adequate explanation for increases in autism diagnoses that run
as high as 2000%.

“An increase of 2000% overall is not simply better diagnosis or
awareness which other papers have argued accounts for about 15%,” he
said in response to the Taylor argument. ”Similarly, the change
in population (remember, our data are prevalence data) is about 35%.
Also, re diagnostic criterion changes: the rate of ASD changes about
20% per year since 1992. Diagostic criterion changes have happened at
most twice, once before the period we cover.”

The Vancouver scientists’ new paper argues that “Aluminum (Al), the
most commonly used vaccine adjuvant, is a demonstrated neurotoxin and a
strong immune stimulator. Hence, adjuvant Al has the potential to
induce neuroimmune disorders.” They note that autism spectrum
disorder is characterized by “dysfunctional immunity and impaired brain
function” which they characterize as the disorder’s “core
deficits.”

They note that in many jurisdictions, the number of recommended
childhood vaccinations has gone up dramatically in the past decades,
and with it, childhood exposure to the aluminum salts that are added to
many vaccines to make them more powerful. (According to the authors,
Canadian protocols call for childhood immunizations that expose
children to aluminum salts as often as 18 times before school entry.
The Public Health Agency of Canada web page (5.)
currently lists just over forty vaccinations that it describes as
routine for children in BC before the age of six. In the US, the Center
for Disease Control (6.) suggests 37 routine vaccinations for children
before age six.

The authors suggest that all this
increased exposure to aluminum via injection (which, they say,
presents a much higher danger of aluminum crossing the blood brain
barrier and entering the central nervous system than occurs when
aluminum enters the body via food) correlates with higher levels of
autism spectrum disorder in the populations of Western developed
nations.

“Analysis of the relevant data shows that the number of vaccinations
recommended prior to school entry increased from 10 in the late 1970s
to 32 in 2010 (18 of which contain Al adjuvants) [16]. During this same
period, the prevalence of autism spectrum disorders (ASD) in the US
also increased by as much as 2000%,” the Tomljenovic/Shaw paper
notes.

The paper also suggests there are parallels between the immunological
profile associated with exposure to aluminum and immunological
phenomena associated with several other diseases, including autoimmune
thyroid disease, multiple sclerosis, systemic lupus erythematosus,
chronic fatigue syndrome, macrophagic myofasciitis and Gulf War
Syndrome.

Tomljenovic and Shaw are persuaded that the correlations they have
observed between exposure to injected aluminum in vaccines and autism
diagnosis rates are more than coincidental, citing their application of
Hill’s criteria (7.) a tool for testing causal relationships in
epidemiology, to their data. According to the authors, the link between
aluminum exposure and autism spectrum disorder meets eight of the nine
criteria in the Hill system, including all four of the criteria
considered most pertinent to neurological disease.

While Tomljenovic and Shaw believe their paper is the first academic
research to persuasively demonstrate a correlation between aluminum
exposure and autism, the literature on aluminum and neurological
disorders is extensive. For example, writing in the New England Journal
of Medicine in 1997, (8.) Bishop, Morley, Day and Lucas found that “
...in preterm infants, prolonged intravenous feeding with solutions
containing aluminum is associated with impaired neurologic
development,” and in 2002, Becaria, Campbell, and Bondy, writing in
Toxicology and Industrial Health, (http://tih.sagepub.com/content/18/7/309.abstract
) observed accumulating evidence suggests that aluminum “… can
potentiate oxidative and inflammatory events, eventually leading to
tissue damage.”

Two Israeli scientists, Yehuda Shoenfeld and Nancy Agmon-Levin,
writing in 2010 in the Journal of Autoimmunity (9.) suggest that
“ In recent years, four conditions: siliconosis, the Gulf war syndrome
(GWS), the macrophagicmyofasciitis syndrome (MMF) and post-vaccination
phenomena were linked with previous exposure to an adjuvant.” The
Israeli scientists make clear in their paper that aluminum adjuvants
are among the compounds of concern in this matter, and they add:

“Formerly, adjuvants were thought to pose little or no independent
threat. Alas, studies of animal models and humans demonstrated the
ability of some of them to inflict autoimmunity and autoimmune diseases
by themselves.”

Still, Tomljenovic and Shaw are scrupulously careful in their paper to
define the limits of their claims. While they find their comparison of
aluminum exposure rates and autism diagnoses across populations, and
the positive results of applying Hill’s criteria to their findings
persuasive, they caution that “Clearly, we cannot draw definite
conclusions regarding the link between Al adjuvants and autism based on
an ecological study such as
the present one and hence the validity of our results remains to be
confirmed.”

They conclude their paper with an urgent call for more comprehensive
research that could validate or disprove their findings, saying “A case
control study with detailed examination of vaccination records and Al
body burden measurements (i.e., hair, urine, blood) in autistic and a
control group of children would be one step toward this
goal.” Despite this call for intellectual caution and further research,
the two scientists do argue that the case for a more thorough look at
assessing the safety of aluminum adjuvants in vaccines has been made,
and should guide future research and practice.

They argue that “it would seem ill advised to exclude
pediatric vaccinations as a possible cause of adverse long-term
neurodevelopmental outcomes, including
those associated with autism.”

In a conversation with the Columbia Journal last summer, Tomljenovic
and Shaw emphasized that they are by no means univocally anti-vaccine.
They cited the tetanus vaccine as one they support. Their research,
they told me, makes the argument for larger scale research into
possible negative impacts of aluminum salts in vaccines, not for a
total retreat from immunization as a public health strategy.

“Our concerns,” said Shaw, “are safety and evidence based medicine.”

Despite all their caution about the need for more research and the
limits to what their current paper proves, the recent Tomljenovic/Shaw
paper places the researchers in a ferociously contested area of medical
research, and some scientists have expressed deep reservations about
the paper.

All of this controversy, it should be noted, takes place in the long
and murky shadow of a notorious scandal involving vaccine research. The
Wakefield controversy revolves around a paper by Wakefield and
co-authors, (10.) since discredited amid allegations of conflict of
interest and falsified data (11.) and withdrawn by the Lancet,
the journal that published it. The Wakefield paper suggested a
connection between MMR (measles, mumps, rubella) vaccination and
autism. It has been widely cited by anti-vaccine groups, especially in
the “verification free zone” of the internet, and is seen by
pro-vaccine authorities as a prime example of bad science fueling
public panic, leading to very unwise choices by parents to avoid
vaccinating their children.

More recently, Wakefield has taken legal steps in early 2012 to contest
negative views of his research, filing a defamation suit against Brian
Deer, the investigative reporter at the centre of criticism of the
Wakefield research, and the editors of the British Medical Journal
based on material Deer published in the BMJ last year.

The debate about vaccine safety is a high stakes matter on several
counts. Lives are at stake, and immense fortunes in drug company
profits. According to a January 2011 article on the
pharmaceutical industry website Drug Discovery and Development
(12.)

“Human vaccines, earlier considered as a low profit yielding business,
have transformed into cash cows for global pharmaceutical giants.
Patents for human and animal vaccines accepted by European and US
patent authorities totaled nearly 250 in 2007.”

In 2010, vaccine sales soared (13.) to $ 28 billion as compared
to $26 billion in 2009, $24 billion in 2008 and $18.5 billion in 2007.

Paul Offit, of the University of Pennsylvania, is the developer of a
very lucrative rotavirus vaccine patent that has made him a millionaire
(14.)
and, as the author of Deadly Choices How the Anti-Vaccine Movement
Threatens Us All, one of the leading pro-vaccine voices in the current
debate. (The academic chair Offit holds at Penn is named after vaccine
pioneer Maurice J. Hilleman, and funded in part by a foundation created
by the pharmaceutical giant Merck.)
(15.)

Offit is critical of the research reported in the Tomljenovic/Shaw
paper. He said in an early October phone interview that the anti
vaccine movement, with its “appeals to fear” was “worse than scientific
illiteracy.” Prior to the interview, Dr. Offit reviewed a copy of the
Vancouver paper provided to him, and concluded that it “should never
have been published.” Offit said that ecological studies such as the
one authored by Tomljenovic and Shaw were not helpful.

In epidemiology, ecological studies, which investigate whole
populations rather than individuals or cohorts which have been matched
for key variables, are commonly viewed as weaker evidence than the gold
standard of case control studies.

“What we need,” Offit said, “is more epidemiological and case
controlled studies.” He seemed unimpressed by the fact that Tomljenovic
and Shaw also call for exactly the same sorts of further research and
more rigorous studies.

Offit believes that vaccination has been the target of irrational
opposition since it was first developed and popularized by Jenner.
(16.) at the end of the 18th century. But he blames the controversial
Wakefield research for sparking a new and very dangerous trend of
vaccine skepticism, which he says has been amplified by irresponsible
media and internet commentary, all leading to decisions by a
significant number of parents not to vaccinate their children. He is
particularly scathing about the role played by Barbara Loe Fisher, who
he characterizes as the founder of the modern US anti-vaccine movement
and of her National Vaccine Information Center. (17.)

While he believes the anti-vaccine movement is weaker now that the
Wakefield research has been discredited, Offit says that anti-vaccine
statements lead to lower levels of vaccination and subsequent
breakdowns in “herd immunity” (the phenomenon that sees the spread of
contagious diseases contained once a certain percentage of a population
has been vaccinated.) He points to outbreaks of Hib, measles and
pertussis (whooping cough) among unvaccinated children in the developed
world, and charges that the Wakefield paper “killed children.”

Offit also questions Tomljenovic and Shw’s concerns about aluminum
adjuvants in vaccines, sayng that “All the evidence, biological and
epidemiological, shows that aluminum is safe.” He does grant that
aluminum can cause some harm, but points out that it is the most common
of all light metals, and insists that the half life of aluminum in the
body is 24 hours. He argues that children get far more aluminum from
food than they do from vaccinations, without any observable harm.

“The choice not to take aluminum adjuvanted vaccines is not risk free,”
he insisted.

One of the physicians responsible for public health in BC, Dr. Monica
Naus, is also skeptical about the Tomljenovic/Shaw paper. Naus,
Associate Medical Director, Epidemiology, Medical Director,
Immunization Programs, BCCDC, and Associate Professor, School of
Population & Public Health, UBC, said in November that a choice not
to vaccinate a child would be drastic, and said that research like Shaw
and Tomljenovic’s “…can have a bad effect.”

Naus believes that, while the etiology of autism has not yet been fully
elucidated, genetic factors are clearly involved. She told the Columbia
Journal that some cases of autism occur well before children are
vaccinated, and that there is some evidence for autism already
manifesting in utero, all of which, in her view, undermines any
suggestion of a link between vaccination and autism. Like Offit, she
maintains that ecological studies are not very useful, and called for
more case controlled and cohort studies to determine whether there is a
link between exposure to aluminum in vaccines and rates of autism
diagnosis.

Naus was scornful of the journal in which Shaw and Tomljenovic
published their research, saying that the Journal of Inorganic
Biochemistry is not a magazine that pediatricians read. She added that
vaccine safety is studied globally and that vaccines are among safest
medical treatments available.

Dr. Christopher Exley is an internationally recognized expert on
aluminum and was the guest editor of the issue of the Journal of
Inorganic Biochemistry that carried the Tomljenovic/Shaw paper. Exley
is Reader in Bioinorganic Chemistry and
Honorary Professor, UHI Millennium Institute at the Birchall
Centre, Lennard-Jones Laboratories, Keele University, Staffordshire, in
the United Kingdom.

In a November interview, Exley emphasized that all the papers published
in JIB are rigorously peer reviewed.

“I recognized that the topic of this paper was potentially
controversial, and it was essential that the research be reviewed by
experts who were likely to be hostile to the findings. This paper went
through a very tough peer review process, and the reviewers called for
major revisions. But no one called for it to be rejected, and once the
revisions were in, the paper was not inflammatory. The only thing left
was science.”

Exley said that one of the experts who provided peer review of the
paper had previously worked with the Food and Drug Administration on
vaccine safety and two were academics with publications of their own on
environmental impacts of aluminum. He added that two of the three
reviewers felt the application of Hill’s criteria to the paper’s
findings was relevant, while one was skeptical on that point.

Told of Dr. Offit’s assertion the paper should not have been published,
Exley said:

“I believe this paper was beneficial. It raises something that I feel
requires further investigation. We know that infants are particularly
vulnerable to aluminum impacts. This is something that should be
discussed. There is nothing wrong with the science in this paper. It is
very solid and tight. The case that aluminum is causal in autism is not
made in the paper, but the case for further research is.”

Also rejecting the claim that Tomljenovic and Shaw’s research should
not be published or discussed is Dr. Rob Tarzwell, clinical instructor
in psychiatry at UBC. Although he is clearly in favor of vaccination,
describing it as “the biggest public health improvement in human
history after clean water,” Tarzwell is partnering with Shaw in
organizing a program of speakers and discussions on vaccine issues at
Green College on the UBC campus (18.) during 2012. The
Columbia Journal has been advised the series will begin in September of
this year with a presentation by Dr. Jennifer Craig, formerly of the
UBC school of nursing , on vaccine history. Details on timing and
on other speakers slated to appear will be on the college website this
summer. The goal, Tarzwell said, is “to demonstrate
that hot topics can be conducted fruitfully. We want to see the highest
form of civilized and scientific discourse.”

Tarzwell, who first met Shaw when they debated vaccine safety issues on
a radio show, said that although he often draws different conclusions
than his UBC colleague, he thinks that open debate is the best way to
settle their differences.

“Although I can see where Paul Offit is coming from in his comments, I
believe that no idea in and of itself should be repressed in a free
society.”

Full disclosure: I have known
Shaw for several years and he has been a visitor to the board of
directors meetings of the BC Civil Liberties Association, on which I
sit, from time to time.)